Responsible for developing, performing, implementing and managing supported by Engineers and Process Experts (Head Manufacturing and Cell Processing Specialist) – the Site aseptic, process validation, shipping validation and revalidation strategies to meet cGMP requirements to ensure that programs are compliant, and Regulatory requirements and related SOPs.
Validation Master Plan
Establish, write, maintain Validation Master Plan (VMP) for manufacturing process, aseptic process, cleaning, and shipping validation, Support Site Head in ensuring that the VMP activities including, annual revalidation process simulation procedures are executed and maintained as defined in VMP
Maintain overview of state of validation at Site and establish the validation project prioritization across site.
Establish and manage the respective validation plans by aligning, coordinating and supervising the prioritization of activities against the business needs. Review risk assessments for validation.
Set local procedures & templates for respective validation documentation and validation master plan, provide guidance to facility impact and component criticality assessments.
Partner with Quality based on feedback (e.g. via division, regulatory inspections, changes in regulations) to establish and maintain common approach and translate that for the site
Partner with the Production, Warehouse, Engineering, and IT to define the process validation/ shipping/equipment/systems qualification interface.
Ensure that the production processing data is monitored
Maintain all activities in an inspection ready status ahead of any internal or external audits to ensure successful inspections e.g. no critical observations related to validation activities.
5-8 years of experience in pharmaceutical Manufacturing, Manufacturing Science & Technology, Technical Development or Quality with 5-7 years of experience in executing (aseptic) process validation, having led and managed validation projects.
Proven process understanding (Pharma, GMP, Regulatory aspects).
Cell and Gene Therapy and/or Aseptic processing experience preferred.
Thorough understanding of manufacturing processes and related process equipment.
Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions).
Fundamental understanding of standard pharmaceutical analytical testing.
Strong leadership and interpersonal skills as well as excellent presentation and scientific/technical writing skills
Source: Job Diva – Job Listing